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Differences in GMP cleanliness and microorganisms among countries

  • Author:Jason Peng

  • Cleanroom Engineering Technology Manager of Deiiang Company.

    Product R&D Manager of GDC Inc. Cleanroom Equipment Manufacturing Company.

    Executive Director of Guangdong Cleanroom Industry Association of China.

    Engaged in R&D of related products for 15 years, with rich relevant technical experience
  • 2024-10-20  |  Visits:

Differences in GMP cleanliness and microorganisms among countries.jpg

The particle size > 5um is controlled by the IS04.8 standard.

Note: China and EU gmp classify clean areas into A, B, C, and D, while USP and iso classify by numbers. The A grade class controls particles > 0.5um by the IS05.0 standard.

Standard for the grade of floating bacteria.jpg

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